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Publication - Dr Cindy Mann

    Protocol for a process evaluation of a cluster randomised controlled trial to improve management of multimorbidity in general practice

    the 3D study


    Mann, C, Shaw, A, Guthrie, B, Wye, L, Man, M-S, Hollinghurst, S, Brookes, S, Bower, P, Mercer, S & Salisbury, C, 2016, ‘Protocol for a process evaluation of a cluster randomised controlled trial to improve management of multimorbidity in general practice: the 3D study’. BMJ Open, vol 6.


    As an increasing number of people are living with more than 1 long-term
    condition, identifying effective interventions for
    the management of multimorbidity in
    primary care has become a matter of urgency. Interventions are
    challenging to evaluate
    due to intervention complexity and
    the need for adaptability to different contexts. A process evaluation
    can provide extra
    information necessary for
    interpreting trial results and making decisions about whether the
    intervention is likely to be successful
    in a wider context. The 3D
    (dimensions of health, drugs and depression) study will recruit 32 UK
    general practices to a cluster
    randomised controlled trial to
    evaluate effectiveness of a patient-centred intervention. Practices will
    be randomised to intervention
    or usual care.

    Methods and analysis
    The aim of the process evaluation is to understand how and why the
    intervention was effective or ineffective and the effect
    of context. As part of the
    intervention, quantitative data will be collected to provide
    implementation feedback to all intervention
    practices and will contribute to
    evaluation of implementation fidelity, alongside case study data. Data
    will be collected
    at the beginning and end of the
    trial to characterise each practice and how it provides care to patients
    with multimorbidity.
    Mixed methods will be used to
    collect qualitative data from 4 case study practices, purposively
    sampled from among intervention
    practices. Qualitative data will be
    analysed using techniques of constant comparison to develop codes
    integrated within a
    flexible framework of themes.
    Quantitative and qualitative data will be integrated to describe case
    study sites and develop
    possible explanations for
    implementation variation. Analysis will take place prior to knowing
    trial outcomes.

    Ethics and dissemination
    Study approved by South West (Frenchay) National Health Service (NHS)
    Research Ethics Committee (14/SW/0011). Findings will
    be disseminated via a final report,
    peer-reviewed publications and practical guidance to healthcare
    professionals, commissioners
    and policymakers.

    Trial registration number ISRCTN06180958.

    Full details in the University publications repository